The Generic Drug and Biosimilar User Fee Act (H.R. 3988) is the result of deliberations between the agency and industry groups, including BPTF, to achieve inspection parity between foreign and domestic firms. Up to 40% of all drugs Americans take are imported, and up to 80% of the active pharmaceutical ingredients in those drugs come from foreign sources. The Government Accountability Office says it would take FDA nine years to inspect all foreign facilities.

“Since 2006, BPTF has been advocating for increased resources for the FDA in order to conduct more inspections of foreign drug ingredient manufacturers,” said BPTF Chair Patty Benson, Quality Assurance Director at SAFC. “This legislation will go a long way in safeguarding our drug supply and result in greater scrutiny of drug manufacturing in high-risk regions of the globe.”

Last year, BPTF and other industry groups negotiated generic drug user fees with FDA at an annual cost to industry of nearly $300 million. The goal is to hold all players contributing to the U.S. generic drug system to the same inspection standards, achieve inspection frequency parity, expedite the availability of more affordable, high-quality generic drugs and enhance FDA’s ability to identify and track registration of contributors involved in each drug product sold in the U.S.

Goals established in the negotiations include a decrease in the time it takes the FDA to review and act on new drug applications, from 31 months to 10 months. The time it takes to get a generic drug approved has nearly doubled, and FDA’s resources have not kept up with the increasing number of applications, with the greatest increase coming from foreign facilities.

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About BPTFThe Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of SOCMA, is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.